Introduction

The University of Virginia applies the categories of research eligible for expedited review, which were published in the Federal Register notice 63, FR 60367, November 9, 2009.

The categories in this list apply regardless of the age of subjects, except as noted in category 2.

The IRB chair, vice chair or an experienced member designee in accordance with the requirements set forth in 45 CFR 46.110 will review the protocol submission and determine if the research meets the criteria for expedited review.

In reviewing the research, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research. When a reviewer cannot approve the research under expedited review, the study is remanded to the full IRB for review at a future IRB meeting.

The UVA IRB-HSR will keep members advised of protocols approved by expedited means by providing written document of all expedited approvals in the full board meeting agenda

Types of research that may not be reviewed by expedited review:

Projects involving classified research cannot be completed by expedited review.

Projects involving identification of the subjects and/or their responses which would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Types of research that may be reviewed by expedited review:

Research activities that

present no more than minimal risk to human subjects, and

involve only procedures listed in one or more of the following categories may be reviewed by the IRB through the expedited review procedures authorized by 45 CFR 46.110 and 21 CFR 56.110.

The activities listed should not be deemed to be of minimal risk simply because they are included on this list.

Inclusion of this list merely means that the activity is eligible for review through the expedited review procedures when specific circumstances of the proposed research involve no more than minimal risk to human subjects.

Though the Federal regulations state that the categories in this list apply regardless of the age of the subject, the vulnerable population stipulations still apply.

Investigators are reminded that the standard requirements for informed consent apply regardless of the type of review utilized by the IRB. Expedited review procedures do not release the investigator from the obligation of obtaining informed consent or authorization from human subjects enrolled in the research.

Expedited Review Criteria

(45 CFR 46.110 and 21 CFR 56.110)

Clinical studies of drugs and medical devices only when conditions (a) or (b) is met:

Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs that significantly increases the risks associated with the use of the drug is not eligible for expedited review.)

Research on medical devices for which

an investigational device exemption (IDE) application is not required; or

the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period, and collection may not occur more frequently than two times per week; or

From other adults and children considering the age, weight, and health of the subjects, the collection procedure, the amount of blood collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period, and collection may not occur more frequently than two times per week.

Prospective collection of biological specimens for research purposes by noninvasive means. Examples:

hair and nail clippings in a non-disfiguring manner;

deciduous teeth at the time of exfoliation or if routine subject care indicates a need for extraction;

uncannulated salvia collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a diluted citric solution to the tongue;

placenta removed at delivery;

amniotic fluid obtained at the time of rupture of the membrane prior to or during delivery;

supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;

Collection of data through non-invasive procedures (not involving general anesthesia or sedation) employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples of non-invasive procedures that may qualify for expedited review are

physical sensors that are applied either to the surface of the body or at a distance and do not involve the input of significant amounts of energy into the subject or an invasion of the subject's privacy;

moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Research involving materials (data, documents, records or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment and/or diagnosis). (Note: Some research in this category may be exempt from IRB regulations for the protection of human subjects (45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

Collection of data from voice, video, digital or image recordings for research purposes.

Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from IRB regulations for the protection of human subjects 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

Continuing review of research previously approved by the IRB as follows:

where

the research is permanently closed to the enrollment of new subjects;

all subjects have completed all research-related interventions; and

the research remains active only for long-term follow-up of subjects; or

where no subjects have been enrolled and no additional risks have been identified; or

where the remaining research activities are limited to data analysis.

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened full IRB meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Examples of types of studies and the review type

Risk

Amount of Review

Types of Studies

No greater than Minimal risk and procedure fits under an expedited review category

use of otherwise discarded tissue obtained during a clinical procedure for clinical purposes (no extra tissue, fluid etc. taken for the research)

nutritional assessments

surveys or questionnaires of a non-sensitive nature

chart reviews and keeping HIPAA identifiers

use of data from an existing database

use of banked specimens for minimal risk research (e.g. not testing of polymorphisms)

buccal swab

database is being developed that contains data gathered from existing sources such as the medical record

where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable , HOWEVER, appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal AND documentation of the application for a Certificate of Confidentiality is submitted prior to approval. (See Certificate of Confidentiality information on the IRB-HSR website)

Minimal Risk however the procedure does NOT fit under an expedited category

Full Board

small amount of additional fluid, tissue is being collected for research purposes and the collection method itself presents greater than minimal risk (collection of additional CSF, biopsy tissue etc.)

randomization to one of several approved drugs/devices

trials with procedures such as indwelling catheters

oral glucose tolerance test

induced sputum,

skin biopsy

imaging studies ( except MRI without contrast)

Greater than Minimal Risk

Full Board

collection of identifiable sensitive information without a Certificate of Confidentiality

clinical trials of an investigational drug

studies that involve randomizing to a placebo group

anything is being ingested, injected or implanted or sprayed into the body such that systemic absorption will occur, even if the item being used is not the item under study.

anything is being introduced into an orifice solely for research, Examples: pap smears, ear probes that are inserted further into the ear than the entrance of the auditory canal; rectal swabs, anything being placed into the nose farther than a finger could go

blood samples for research are being collected from an existing peripheral or central line.

additional CSF is being collected from an existing shunt or externalized CSF drain.

studies involving subjects with illnesses begin treated with study procedures that may result in moderate to severe adverse events

assessments, surveys or questionnaires of a sensitive nature where HIPAA identifiers will be retained

databases that contain sensitive information that is identifiable and NO Certificate of Confidentiality will be sought

clinical trials of diseases where the endpoints are major morbidity or mortality

assessment of serious toxicity requiring comparison of toxicity rates

implantation of a device with an IDE

use of a new chemical or drug for which there is limited or no available safety data in humans

gene transfer

multicenter trials involving greater than minimal risk to subjects

high risk clinical procedures if performed solely for research purposes

classified research involving human subjects

where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable AND no documentation of the application for a Certificate of Confidentiality is submitted prior to approval. (See Certificate of Confidentiality information on the IRB-HSR website

subjects are being randomized to different standard of care treatment groups and the standard of care present greater than minimal risk. (For example: the standard of care involves treatments with drugs or devices (whether approved or not approved). (See Attachment # 1 of this document for more information.)

the researcher, or a research assistant, is in a position of power over the participants (e.g., an instructor or professor),

there is potential for participants to perceive coercion to participate in the research (e.g., the professor will find out whether students participated in the research, there is a very high payment for participating),

If you have questions, concerns, suggestions about research, a reserach-related injury or questions about the rights of a reserach participant, you may call the Office of the Vice President for Research (VPR) at 434.924.6853 and leave a message. A member of the VPR staff will contact you to address your questions or concern.

If you would like to submit a concern anonymously you may send a letter to: VPR, P.O. Box 400301, Charlottesville, VA, 22904